RADIO PHARMACEUTICALS Introduction Advantage application Storage. Presented by: Bimal Gharti Magar Pharma D 1
DEFINITION: Radiopharmaceuticals are the radioactive substances or radioactive drugs for diagnostic or therapeutic interventions. or Radiopharmaceuticals are medicinal formulations containing radioisotopes which are safe for administration in humans for diagnosis or for therapy . Radioisotope A version of a chemical element that has an unstable nucleus and emits radiation during its decay to a stable form. All isotopes are not radioisotopes . 2
Radioactivity Alpha Rays Alpha rays are the positively charged particles. Alpha-particle is highly active and energetic helium atom that contains two neutrons and protons. Beta Rays Beta particles are extremely energetic electrons that are liberated from the inner nucleus. A neutron in the nucleus splits into a proton and an electron on the emission of a beta particle. Gamma Rays They are the most penetrating but least ionizing and very difficult to resist them from entering the body.
Advantage It can be used as diagnosis and treatment of patients It is common cure to cancers Can treat multiple disease sites Directly treats tumor, especially useful for bone metastasis Can provide fast onset of pain relief Single dose is effective for some patients Nuclear medicine can be safely use on children cost effective and painless Nuclear medicine procedures have no side effects and are completely safe 4
5 Disadvantage Nuclear medicine is not recommended for the pregnant and breastfeeding woman Nuclear medicine may cause an allergic reaction in some cases Specific consideration should be followed before starting the nuclear medicine in some cases The high cost of nuclear medication Side effects related to nuclear medicine Nuclear medicine may consume a long time Filling in patients' teeth, dental braces and permanent bridges may cause some distortion around the mouth area
STORAGE Isotope storage areas should be as per the rules, there should be separate labs Store in an airtight , suitable labeled containers shielded by lead bricks to protect personnel from exposure intended for parental use should be stored in such a manner so that purity of the product is maintained. 6
DISPENSING OF RADIOPHARMACEUTICALS Radiopharmaceuticals never go delivery to the patient. They are provide to trained health care professionals at the hospital or clinic and then administered to the patient therefore radiopharmaceuticals are dispensed in a unit dose. Patient factors such as age, weight, surface area, gamma, camera sensitivity must be weighed and consider by the pharmacist with each other . If the pharmacist; dosage form of radiopharmaceuticals used they should be administered by aseptic techniques. 7
APPLICATIONS Radioisotopes and radiopharmaceuticals are widely used in many branches of medicine and surgery. Diagnostic applications Radiotherapy Sterilization techniques. Research applications Radioiodine (iodine-131) was first introduced in 1946 for the treatment of thyroid cancer & hyperthyroidism 8
Diagnostic applications: Radiation for diagnostic purpose must have sufficient energy to pass through tissues from inside the body to detecting device. Phosphorous – 32 ( 15 P 32 ): This is used as sodium phosphate for diagnosis of malignant neoplasamas affecting eye, brain & skin. Chrominium – 51 ( 24 Cr 51 ): Chrominium – 51 as sodium chromate sterile solution is used to label RBC to measure their survival, volume & gastrointestinal blood losses. Cobalt – 57 ( 27 Co 57 ) & Cobalt – 58 ( 27 Co 58 ): These are labeled with Cynacobalamine ( Vit - B12) preparations for measurement of absorption, diagnosis of pernicious anemia and other malabsorption syndromes. 9
Technetium-99m: Technetium-99m is the most widely used radioisotope in diagnostic nuclear medicine Technetium- 99m complexes, are used for imaging the thyroid, liver, bone, kidneys etc. 10
2. Radio Therapy: Radio isotopes are used for therapeutic action. The Principle of radiotherapy is to destroy diseased tissues with out destroying healthy tissues. Iodine-131 These are used in study of thyroid function, in treatment of thyrotoxicosis & thyroid carcinoma. Yttrium – 90 This is used as colloid al suspension of Yttrium silicate in treatment of arthritic conditions of joints. Phosphorus – 32 Sodium phosphate is used in treatment of polycythaemia by I.V injection. 11
3. Sterilization techniques: Radio isotopes are employed in radiation sterilization of heat liable drugs like hormones, vitamins, antibiotics etc ., Cobalt – 60 This is used as radiation source for sterilization by γ - irradiation of disposable syringes, catheters and surgical dressings. 4. Research applications: Radioisotopes are used in biochemical research for determination of mechanism of reaction, locus of action. Iodine – 131: Sodium iodohippuric is used in determination of effective renal plasma flow. 12
13 Role of Nuclear Pharmacist in Radiopharmaceuticals Procurement of radiopharmaceutical : Pharmacist is responsible for the procurement of drugs Compounding of radiopharmaceuticals: The prescriber get all the information related from radio-pharmacist, then he/she prescribe According to the list provided by the physician a day prior to the administration, pharmacist starts preparing radiopharmaceutical . Dispensing of radiopharmaceutical: After getting the prescription, radio pharmacist makes necessary calculation for proper dispensing. A proper label is affixed properly with all information in the vial and activity measured at specific time, Distribution of radiopharmaceutical: Radiopharmacist involve in distribution of correct and safe dosage form with appropriate labelling , packaging and transportation
14 Quality assurance : Quality assurance of radiopharmaceutical, instrument, equipment and device is necessary for the practice. Research and development: They do participate in design, evaluation, formulation, QC and clinical trial of new radiopharmaceutical . Monitoring of patient's outcome : Radiopharmacist are responsible for optimal patient outcome within the scope of their practices . Provision of information and consultation: Healthy and safety: Radiopharmacist are responsible for safeguarding the health and safety of themselves, co-workers, patients and public.
15 Skills required in radio- pharmacist A working knowledge of pharmaceutical sciences including microbiology, chemistry, physiology/pharmacology together with some radiation physics provides the essential academic background required of a radiopharmacist or radio-pharmaceutical scientist . In addition, practical skills in aseptic manipulation, and in the safe handling of radioactive products are required . A knowledge of analytical techniques including chromatography, gel filtration and electrophoresis is useful in relation to quality control, and in research and development activities . it is necessary to be aware of proper procedures, bearing in mind the dual nature of radiopharmaceuticals as both medicines and radioactive products.
16 Prevention of Radiation Hazard Time : The process must be carried out as rapidly as possible with proper technique . Distance : A voiding direct contact with such items and by using long forceps, remote handling tongs, gloves are the appropriates technique. Shielding: lead, plastic, glass, aluminium etc. are used for shielding Intensity : it is not recommended to work unnecessarily with high strength of radioactivity . Educating the person working there regarding safety and hazards . Duty should be confined to the assigned area. Knowing the rules, area designation and sign set for handling the materials. Perform the activity ideally with minimal production of waste. Prevention of spills and spread of contamination outside the laboratory. Using proper safety clothing, gloves and goggles etc.
17 Labeling and Packaging of Radiopharmaceuticals The label on the package should have the following information . The name of the product and also added radionuclide . The code of the product . date and time of the manufacturing . The name of the manufacturing company and batch number . For liquid preparations, the total volume in the vial, and the total concentration of radionuclide within the vial or the conc./ml For solid preparations the total amount of radionuclide For capsules, the total number of capsules in the package and also the amount of radionuclide in each capsule . All ingredients should be mentioned in the label . The route of administration and the expiration date . Specific storage conditions . Packaging : The packing and labeling materials should be suitable for the condition of the product.